Healthy AgingNCT04088552
Preventing Chronic Disease: ActuaYa
A study testing Go4Life-Physical Activity/Exercise Program "Workout to Go" 5 and ActuaYa Educational Sessions in people with Healthy Aging, run by University of Miami at 1 site in United States.
Trial summary
The purpose of the study is to help older Hispanic women to increase physical activity, reach a healthy body weight, increase self-esteem and mood and increase knowledge about chronic diseases such as hypertension, diabetes, and HIV. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Go4Life-Physical Activity/Exercise Program "Workout to Go" 5 and ActuaYa Educational Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2020to 29 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must self-identify as a Hispanic woman
- Must be aged 50 years or older
- Must not already be engaging in exercise for >150 minutes per week
- Must be able to ambulate without the use of assistive devices
- Must have an intelligent phone iOS or Android
- Must be willing and able to participate in the informed consent process.
Who cannot join
- Participants that do not meet the above-mentioned criteria.
- In the opinion of the investigator, have any clinical condition that would make the participant unsuitable to participate.
- Participants who are currently participating in another investigational study.
- Participants that need a medical clearance for exercise based on the American College of Sports Medicine exercise participation algorithm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Chronic Disease (HIV, Diabetes, Hypertension, Obesity) Among Older Hispanic Women in Broward
The purpose of the study is to help older Hispanic women to increase physical activity, reach a healthy body weight, increase self-esteem and mood and increase knowledge about chronic diseases such as hypertension, diabetes, and HIV.
- Conditions
- Healthy Aging
- Being tested
- Go4Life-Physical Activity/Exercise Program "Workout to Go" 5, ActuaYa Educational Sessions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go4Life-Physical Activity/Exercise Program "Workout to Go" 5Other
The Go4Life-Physical Activity/Exercise Program "Workout to Go" 5 Program is an exercise regimen provided to participants. Participants will be provided a booklet with exercise routines that requires minimal equipment and can be performed anywhere for approximately 30 minutes per session. Recommendation on staying active by increasing daily steps through walking will also be recommended as part of the regimen.
ActuaYa Educational SessionsBehavioural
The ActuaYa Educational Sessions will be delivered by a facilitator in 3 separate sessions with each session lasting 2.5 hours for a total of 7.5 hours administered for the study duration. Each session will be conducted in separate groups of 6-10 participants. Session 1 will discuss the impact of chronic disease in the older Hispanic community. Session 2 will discuss the communication and negotiation with the family and partner. Session 3 will discuss saying goodbye and having a plan for a healthy lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| ActuaYa Arm | Experimental | Participants will receive educational sessions, facilitated discussions and an exercise program. Receives: Other: Go4Life-Physical Activity/Exercise Program "Workout to Go" 5; Behavioral: ActuaYa Educational Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean Hemoglobin A1C (HbA1c) levels
HbA1c will be measured from finger stick blood sample.
Measured: Baseline, 6 months
Change in Blood Pressure
Changes in blood pressure will be measured using a manual sphygmomanometer by a registered nurse.
Measured: Baseline, 6 months
Change in Body Mass Index (BMI)
BMI will be measured by weight and height using the formula: 703 multiplied by the weight in lbs divided by the square of height in inches.
Measured: Baseline, 6 months
Change in self-efficacy for condom use
Measured using the HIV self-efficacy for condom use survey. Scores range from 7-28. A higher score indicates a higher level of self-efficacy for condom use.
Measured: Baseline, 6 months
Change in nutritional habits
Change in nutritional habits will be evaluated via the Healthy Eating Index (HEI) using the self-reported data from the nutrition survey. The HEI scores range from 0 to 100 with a higher score indicating healthier eating habits with food intake aligning with key dietary recommendations from the Dietary Guidelines for Americans.
Measured: Baseline, 6 months
Change in active lifestyle as assessed by daily steps
Change in active lifestyle will be assessed by the amount of daily steps taken as assessed using a study provided wrist pedometer.
Measured: Baseline, 6 months
Change in active lifestyle as assessed by a self-report log
Change in active lifestyle will be assessed by the number of days per week the participant completed the recommended 30-minutes exercise via a self-report log.
Measured: Baseline, 6 months
Change in active lifestyle as assessed by the Exercise Survey
Change in active lifestyle will be assessed using the Exercise Survey. The exercise survey is a 19-item survey with each item having a score ranging from 0-10. A higher total score indicates a higher level of physical activity.
Measured: Baseline, 6 months
Change in active lifestyle as assessed by the Exercise Question Survey
Change in active lifestyle will be assessed using the Exercise Question Survey. The exercise survey is a 9-item survey with total score ranging from 0-90. A higher total score indicates a higher level of physical activity.
Measured: Baseline, 6 months
Change in HIV risk behaviors
Change in HIV risk behaviors will be assessed using the Partner Table Survey. The Partner Table Survey is a 5-item survey with a total score ranging from 1-17 with a higher score indicating a higher HIV risk behavior.
Measured: Baseline, 6 months
Change in body fat composition
Measured using a bioelectrical impedance analysis.
Measured: Baseline, 6 months
Change in abdominal circumference
Measured using a measuring tape.
Measured: Baseline, 6 months
Secondary outcomes (11)
Change in knowledge regarding obesity
Change in knowledge regarding obesity will be measured using the obesity knowledge and risk perception questionnaire. For obesity knowledge, the scores range from 6-12. A higher score indicates a lower level of obesity-related knowledge.
Measured: Baseline, 6 months
Change in risk perception regarding obesity
Change in risk perception regarding obesity will be measured using the obesity knowledge and risk perception questionnaire. For obesity risk perception, the scores range from 3-9. A higher score indicates a lower level of obesity risk perception.
Measured: Baseline, 6 months
Change in knowledge regarding diabetes
Change in diabetes knowledge will be measured using the Diabetes Knowledge Questionnaire (DKQ-24). It is a 24 item questionnaire wherein a score of 17 or more correct responses indicate sufficient diabetes knowledge and a score of 6 or less correct responses indicate insufficient diabetes knowledge.
Measured: Baseline, 6 months
Change in HIV knowledge
Change in HIV knowledge will be measured via the HIV Knowledge Scale. The score ranges from 0-12 with a higher score indicating a higher level of HIV-related knowledge.
Measured: Baseline, 6 months
Change in HIV risk perception
Change in HIV risk perception will be measured via the HIV Risk Perception Scale. The total score ranges from 4-14 with a higher score indicating a higher level of HIV-related knowledge.
Measured: Baseline, 6 months
Change in self-esteem
Change in self-esteem will be measured by the Rosenberg Self-Esteem Scale via interview. The total score ranges from 0 to 30 with a score of 14 and less indicating low self-esteem.
Measured: Baseline, 6 months
Change in depressive symptoms as assessed by the CES-D20
Change in depressive symptoms will be measured using the Center for Epidemiologic Studies Depression Scale (CES-D20). The CES-D20 has a total score ranging from 0 to 60 with a higher score indicating greater depressive symptoms.
Measured: Baseline, 6 months
Change in depressive symptoms as assessed by the GDS
Change in depressive symptoms will be measured using the Geriatric Depression Scale (GDS). The GDS has a total score ranging from 0-15 with a higher score indicating higher depressive symptoms. A score of 6 to 9 indicates suggestive depressive symptoms and a score of 10 to 15 indicates depressive symptoms.
Measured: Baseline, 6 months
Change in health care related habits
Change in healthcare related habits is measured via the Health Care-Related Factors Questionnaire. The total score ranges from 26 to 43 with a higher score indicating lesser health care related habits.
Measured: Baseline, 6 months
Change in technology use
Change in technology use will be measured using a questionnaire assessing ability to use technology (pedometer, smartphones, apps, internet). The total score ranges from 13-26 with a higher score indicating a lower ability to use technology.
Measured: Baseline, 6 months
Change in knowledge regarding hypertension
Change in knowledge regarding hypertension is measured using the Hypertension Survey. The Hypertension Survey is a 10-item survey with a totals score ranging from 0-10 with a higher score indicating increased knowledge regarding hypertension.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start7 Mar 2020
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The Community Foundation of Broward
- Responsible party
- Principal investigator, Rosina Cianelli, University of Miami
- Investigators
- Rosina Cianelli, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088552
- Sponsor's protocol ID
- 20190373
- Status last verified
- Oct 2021
- First submitted
- 11 Sep 2019
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Chronic Disease (HIV, Diabetes, Hypertension, Obesity) Among Older Hispanic Women in Broward
- ClinicalTrials.gov ID
- NCT04088552
- Acronym / sponsor ID
- 20190373
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The Community Foundation of Broward
- Study start
- 7 Mar 2020 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to help older Hispanic women to increase physical activity, reach a healthy body weight, increase self-esteem and mood and increase knowledge about chronic diseases such as hypertension, diabetes, and HIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ActuaYa Arm | Experimental | Other: Go4Life-Physical Activity/Exercise Program "Workout to Go" 5, Behavioral: ActuaYa Educational SessionsParticipants will receive educational sessions, facilitated discussions and an exercise program. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must self-identify as a Hispanic woman
- Must be aged 50 years or older
- Must not already be engaging in exercise for >150 minutes per week
- Must be able to ambulate without the use of assistive devices
- Must have an intelligent phone iOS or Android
Key exclusion criteria (4 listed)
- Participants that do not meet the above-mentioned criteria.
- In the opinion of the investigator, have any clinical condition that would make the participant unsuitable to participate.
- Participants who are currently participating in another investigational study.
- Participants that need a medical clearance for exercise based on the American College of Sports Medicine exercise participation algorithm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Go4Life-Physical Activity/Exercise Program "Workout to Go" 5The Go4Life-Physical Activity/Exercise Program "Workout to Go" 5 Program is an exercise regimen provided to participants. Participants will be provided a booklet with exercise routines that requires minimal equipment and can be performed anywhere for approximately 30 minutes per session. Recommendation on staying active by increasing daily steps through walking will also be recommended as part of the regimen. | Other | ActuaYa Arm |
| ActuaYa Educational SessionsThe ActuaYa Educational Sessions will be delivered by a facilitator in 3 separate sessions with each session lasting 2.5 hours for a total of 7.5 hours administered for the study duration. Each session will be conducted in separate groups of 6-10 participants. Session 1 will discuss the impact of chronic disease in the older Hispanic community. Session 2 will discuss the communication and negotiation with the family and partner. Session 3 will discuss saying goodbye and having a plan for a healthy lifestyle. | Behavioural | ActuaYa Arm |
Primary outcome
Change in mean Hemoglobin A1C (HbA1c) levels
Time frame: Baseline, 6 months
HbA1c will be measured from finger stick blood sample.
Change in Blood Pressure
Time frame: Baseline, 6 months
Changes in blood pressure will be measured using a manual sphygmomanometer by a registered nurse.
Change in Body Mass Index (BMI)
Time frame: Baseline, 6 months
BMI will be measured by weight and height using the formula: 703 multiplied by the weight in lbs divided by the square of height in inches.
Change in self-efficacy for condom use
Time frame: Baseline, 6 months
Measured using the HIV self-efficacy for condom use survey. Scores range from 7-28. A higher score indicates a higher level of self-efficacy for condom use.
Change in nutritional habits
Time frame: Baseline, 6 months
Change in nutritional habits will be evaluated via the Healthy Eating Index (HEI) using the self-reported data from the nutrition survey. The HEI scores range from 0 to 100 with a higher score indicating healthier eating habits with food intake aligning with key dietary recommendations from the Dietary Guidelines for Americans.
Change in active lifestyle as assessed by daily steps
Time frame: Baseline, 6 months
Change in active lifestyle will be assessed by the amount of daily steps taken as assessed using a study provided wrist pedometer.
Change in active lifestyle as assessed by a self-report log
Time frame: Baseline, 6 months
Change in active lifestyle will be assessed by the number of days per week the participant completed the recommended 30-minutes exercise via a self-report log.
Change in active lifestyle as assessed by the Exercise Survey
Time frame: Baseline, 6 months
Change in active lifestyle will be assessed using the Exercise Survey. The exercise survey is a 19-item survey with each item having a score ranging from 0-10. A higher total score indicates a higher level of physical activity.
Change in active lifestyle as assessed by the Exercise Question Survey
Time frame: Baseline, 6 months
Change in active lifestyle will be assessed using the Exercise Question Survey. The exercise survey is a 9-item survey with total score ranging from 0-90. A higher total score indicates a higher level of physical activity.
Change in HIV risk behaviors
Time frame: Baseline, 6 months
Change in HIV risk behaviors will be assessed using the Partner Table Survey. The Partner Table Survey is a 5-item survey with a total score ranging from 1-17 with a higher score indicating a higher HIV risk behavior.
Change in body fat composition
Time frame: Baseline, 6 months
Measured using a bioelectrical impedance analysis.
Change in abdominal circumference
Time frame: Baseline, 6 months
Measured using a measuring tape.
11 secondary outcomes
Change in knowledge regarding obesity
Time frame: Baseline, 6 months
Change in risk perception regarding obesity
Time frame: Baseline, 6 months
Change in knowledge regarding diabetes
Time frame: Baseline, 6 months
Change in HIV knowledge
Time frame: Baseline, 6 months
Change in HIV risk perception
Time frame: Baseline, 6 months
Change in self-esteem
Time frame: Baseline, 6 months
Change in depressive symptoms as assessed by the CES-D20
Time frame: Baseline, 6 months
Change in depressive symptoms as assessed by the GDS
Time frame: Baseline, 6 months
Change in health care related habits
Time frame: Baseline, 6 months
Change in technology use
Time frame: Baseline, 6 months
Change in knowledge regarding hypertension
Time frame: Baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosina Cianelli, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Go4Life-Physical Activity/Exercise Program "Workout to Go" 5 and ActuaYa Educational Sessions in people with Healthy Aging, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean Hemoglobin A1C (HbA1c) levels (time frame: Baseline, 6 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021; AzTrials last refreshed its copy on 31 Oct 2026.